FDA 483 - Diane Highum, M.D. - June 27, 2019

An FDA inspection of Diane Highum, M.D., Clinical Investigator in Bellflower, CA, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to the investigational plan, with issues including widespread backdating of subject progress notes and study summary sheets. Additionally, non-qualified personnel performed critical study tasks, and caregivers were inappropriately used across multiple subjects, raising concerns about data integrity and protocol compliance.